NCT04704193

Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes

Completed NA Results posted Last updated 13 August 2024

What this trial tests

NA trial testing Survey of Decision Aid in Genetic Testing in 93 participants. Completed in 31 December 2023.

Timeline

20 November 2020

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	93
Start date	20 November 2020
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Survey of Decision Aid

Conditions studied

• Genetic Testing — all drugs for Genetic Testing →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Genetic Testing. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participant Satisfaction With How Educational Information is Presented in the Decision Aid Primary · This outcome will be measured immediately following completion of the decision aid. The average completion time of the decision aid is 14 minutes.

Measured with 6 items on a questionnaire that asks participants to rate the way certain information is presented on the decision aid. Each item is rated on a scale of 1 to 4, with 1 being poor and 4 being excellent.

Genetic testing is a blood test that looks for mutations in genes that can increase cancer risk

Group	Value	95% CI
Electronic Decision Aid	1
Electronic Decision Aid	3
Electronic Decision Aid	29
Electronic Decision Aid	55

Genetic test results may help guide my treatment options

Group	Value	95% CI
Electronic Decision Aid	2
Electronic Decision Aid	4
Electronic Decision Aid	30
Electronic Decision Aid	51

Genetic test results may help me understand the future risks of other cancers

Group	Value	95% CI
Electronic Decision Aid	1
Electronic Decision Aid	4
Electronic Decision Aid	26
Electronic Decision Aid	57

Genetic test results may increase stress to me and my family members

Group	Value	95% CI
Electronic Decision Aid	5
Electronic Decision Aid	8
Electronic Decision Aid	33
Electronic Decision Aid	41

There are 3 gene panel options that include either a small, medium, or large number of genes

Group	Value	95% CI
Electronic Decision Aid	2
Electronic Decision Aid	4
Electronic Decision Aid	31
Electronic Decision Aid	50

Gene test results may come back as positive, negative, or uncertain

Group	Value	95% CI
Electronic Decision Aid	1
Electronic Decision Aid	6
Electronic Decision Aid	33
Electronic Decision Aid	46

Total Time Spent on Decision Aid Secondary · From the start of the decision aid to the completion of the decision aid

The total amount of minutes spent on the decision aid

Group	Value	95% CI
Electronic Decision Aid	13.7	± 5.6

Sponsor's own description

An electronic decision aid will be used to assist individuals in choosing a multi-gene panel with their medical oncologist instead of a genetic counselor. A decision aid may facilitate quality decisions around the selection of a specific multi-gene panel without a genetic counselor. Upon completion of the decision aid, participants will be asked to indicate their decision about whether to pursue genetic testing and which specific multi-gene panel to pursue. A survey will then be administered to assess participants' opinions on the decision aid.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Feasibility and acceptability of an electronic decision aid for genetic testing in ovarian and pancreatic cancer patients.
   Lynch DA, Wiser S, Patel D, Patel K, et al · · 2026 · PMID 42058480 · DOI 10.1093/rescon/vmag026